ISRCTN - ISRCTN17195095: Small particle steroid study

Plain English Summary

Background and study aims
The small airways (that carry air in and out of the lungs) have become increasingly important in asthma. We now have non-invasive tests of small airways function at our disposition, as well as inhaled drugs (containing smaller aerosol particles) targeting asthma at the level of the small airways. The aim of this study was to assess whether inhaled medications targeting the small airways offer any benefit over regular asthma drugs in terms of lung function (and more specifically small airways function) and asthma control. In addition the study will provide useful information about the inflammatory and structural alterations in the small airways.

Who can participate?
Non-smoking asthma patients, both male and female, over 18 years old on inhaled corticosteroids ("controller" drugs for asthma) and with abnormalities in the small airways can participate. Pregnant women were excluded from the study.

What does the study involve?
The study involved two patient groups: during a 15 week period the first group was treated with inhaled asthma medications targeting the small airways, whereas patients in the second group remained on regular asthma drugs. Lung function tests were performed before starting and after 3, 9 and 15 weeks. At each of those time point patients were also asked to fill out a short questionnaire (5 minutes) about their asthma. Each of the four study visits took approximately 1 hour. The asthma treatment was not interrupted throughout the entire study.

What are the possible benefits and risks of participating?
Study medication will be provided without any cost. No additional side effects are expected from the study medication, other than those related to the regular asthma treatment patients are already on. There are no risks associated with the lung function testing.

Where is the study run from?
The study took place in the UZ Brussel's (university hospital) outpatient clinic.

When is the study starting and how long is it expected to run for?
The study started in September 2009 and ran until August 2012.

Who is funding the study?
This study was funded by UCB Pharma.

Who is the main contact?
Dr Shane Hanon
shane.hanon@uzbrussel.be

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shane Hanon

ORCID ID

Contact details

Laarbeeklaan 101
Brussels
1090
Belgium
-
shane.hanon@uzbrussel.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Small particle steroid study: a randomized double blind double dummy study

Acronym

Study hypothesis

The residual lung function abnormalities in the small airways of the conductive and acinar lung zone could be smaller with the ultrafine anti-inflammatory aerosol [beclomethasone dipropionate (HFA-BDP); QVAR)] than with a regular anti-inflammatory aerosol [budesonide (DPI-BUD); Pulmicort TH)] in asthma patients with pre-existing small airways dysfunction.

Ethics approval

Medical Ethics Committee of UZ Brussel, 02/04/2009, ref: 2009/043, B.U.N. B14320096121

Study design

Randomized double-blind double-dummy study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet [available in Dutch and French]

Condition

Asthma / Small airways

Intervention

After a 3-week run-in on DPI-BUD patients are randomized to either arm 1 (DPI- BUD switched to BDP-HFA from wk 4 to wk 15) or to arm 2 (remaining on DPI-BUD)

The intervention takes 15 weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

Qvar (beclomethasone dipropionate), Pulmicort (Budesonide)

Primary outcome measure

Change in Sacin (Multiple Breath Nitrogen Washout test). Sacin is a measure of ventilation heterogeneity in the acinar lung zone. Sacin increases with increasing heterogeneity. Measured at baseline and after 3, 9 and 15 weeks.

Secondary outcome measures

1. Alveolar and bronchial exhaled NO
2. Lung function parameters
3. Asthma control test (ACT) score
Measured at baseline and after 3, 9 and 15 weeks.

Overall trial start date

01/09/2009

Overall trial end date

31/08/2012

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Well-established, stable asthma patients on inhaled corticosteroids
2. Age >18 years, male/female
3. Elevated baseline Sacin (>0.12 L-1)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

35

Participant exclusion criteria

1. Smoking history (> 10 packyears) or current smokers
2. Pregnant women

Recruitment start date

01/09/2009

Recruitment end date

31/08/2012

Locations

Countries of recruitment

Belgium

Trial participating centre

Laarbeeklaan 101
Brussels
1090
Belgium

Sponsor information

Organisation

University Hospital Brussels (Universitair Ziekenhuis Brussel [UZ Brussel]) (Belgium)